Skip to content

Klaxon (Twist); Klaxon (Twist R)

by Klaxon Mobility GmbH

510(k) K240267

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240267↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK240267 Date10 Jan 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
ITI
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 890.3860
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Klaxon (Twist) and Klaxon (Twist R) are Powered Wheelchairs designed for mobility assistance. These devices provide electric propulsion for users with limited mobility, featuring adjustable controls and seating configurations to accommodate varying user needs and postures. Their primary function is to enhance independence and mobility for individuals requiring powered mobility solutions.

These wheelchairs are intended for home, clinical, or community use and are supplied as single-use or reusable devices, depending on the model and configuration. They are not sterile and are classified under FDA Class II and MDR (Medical Device Regulation). The Klaxon (Twist) and Klaxon (Twist R) are authorized under FDA 510K clearance and MDR compliance, with specific registration numbers (e.g., 9615350, 9615410) and product codes (ITI). Storage and maintenance instructions are provided by the manufacturer to ensure proper functionality and longevity.

Other devices from Klaxon Mobility GmbH

See all devices from Klaxon Mobility GmbH →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Are the Klaxon (Twist) and Klaxon (Twist R) wheelchairs designed for single-use only, or can they be reused after cleaning and maintenance?

    The Klaxon (Twist) and Klaxon (Twist R) are supplied as either single-use or reusable devices, depending on the specific model and configuration. The manufacturer provides storage and maintenance instructions to ensure proper functionality and longevity for reusable units, so reuse is possible if following those guidelines.

  • What types of environments or settings are these powered wheelchairs intended for, and how does that affect their use?

    The Klaxon (Twist) and Klaxon (Twist R) are designed for home, clinical, or community use, meaning they can be used in residential settings, healthcare facilities, or public spaces. Their adjustable controls and seating configurations help accommodate varying user needs and postures, making them versatile for different mobility requirements.

  • Are these wheelchairs sterile, or do they require additional preparation before use?

    The Klaxon (Twist) and Klaxon (Twist R) are not sterile devices. Since they are intended for mobility assistance in home, clinical, or community settings, they are not packaged or handled under sterile conditions. Proper cleaning and maintenance (where applicable) are recommended before and after use to ensure hygiene.

  • What regulatory pathways have these devices undergone, and how does that impact their availability?

    The Klaxon (Twist) and Klaxon (Twist R) have received FDA 510(k) clearance and comply with the EU Medical Device Regulation (MDR). They are classified under FDA Class II and fall under the ITI product code (Wheelchair, Powered). This regulatory status ensures they meet safety and performance standards for powered mobility devices in the U.S. and EU markets.

  • How do I determine which model—Twist or Twist R—is best suited for a specific user’s needs?

    The primary distinction between the Klaxon (Twist) and Klaxon (Twist R) lies in their supply configuration: the Twist is typically supplied as a single-use or reusable model depending on the setup, while the Twist R is explicitly designed for reusable applications (as indicated by the 'R' suffix). The choice depends on whether the user or facility requires a disposable or long-term, maintained wheelchair. Both models feature adjustable controls and seating for customization.